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510(k) K855112

DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS by Pacific Union Dental, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Pacific Union Dental, Inc.

  • K863500 — STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (September 22, 1986)
  • K860817 — ROOT CANAL ORGANIZER (March 17, 1986)
  • K855111 — DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES (March 6, 1986)
  • K855113 — FLOSS HOLDER (PLASTIC) (March 6, 1986)

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